vitro diagnostic medical device Articles
-
Nanostics Receives CE Mark for its ClarityDX Prostate Test to Detect Clinically Significant Prostate Cancer
Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark. A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries. The ClarityDX Prostate® test provides patients ...
-
What is an IVD Medical Device? Mic Provides a Compact Option
The global COVID-19 pandemic has spurred on a new demand for diagnostic equipment and products in the race to minimise spread. Airports, workplaces, border checkpoints, hospitals and countless other facilities - they’ve all needed accurate qPCR testing capabilities. ...
-
Medical Device Regulation - Indian Perspective
The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you